Pulsed Short Wave Therapy In Cesarean Section

Postoperative Pain Clinical Trial

Official title:

Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03604068
• Other study ID #: PRO180401
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2018
• Source: BioElectronics Corporation
• Contact: Mahmoud Maassarani, Ph.D
• Phone: 79156547
• Email: M.maassarani[@]outlook.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.

Description:

Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Voluntarily

• Performed using spinal anesthesia

• ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)

• PARA 0000, 1, 2, 3 [i.e. First, Second, or Third C-Section)

• At term pregnancy (>38 weeks)

• BMI <35

• Age between 18 - 50 years

Exclusion Criteria:

• Longitudinal surgical incision

• Placental abnormalities noted

• Time of extraction of the fetus >10 min from cutaneous incision

• Blood loss during surgery of >800 ml

• Any of the conditions not considered in inclusion criteria

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• RecoveryRx
A pulsed shortwave therapy medical device
• Sham RecoveryRx
A sham pulsed shortwave therapy medical device

Locations

Country	Name	City	State
Lebanon	Haykal hospital	Tripoli
Lebanon	New Mazloum Hospital	Tripoli

Sponsors (1)

Lead Sponsor	Collaborator
BioElectronics Corporation

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Use	Quantify the use of analgesic medications during 7 days of postoperative recovery.	Data collected daily for 7 Days
Secondary	Change in Visual Analogue Pain	The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain will be measured daily over a 7 day recovery period	Data collected for 7 Days
Secondary	Time to patient Patient Mobility	The benefits of mobility outlined in current nursing textbooks indicate that "Early ambulation is the most significant general nursing measure to prevent postoperative complications". There the time in hours after the c-section operation when the patient becomes mobile(walking) will be used recorded.	2 Days
Secondary	Would Closure at Day 7, Wound Complications	presence of edema, erythema,hematoma, and exudate from the surgical wound on the seventh postoperative day that could impair woundhealing process	7 Days